About the Precision Medicine Initiative Cohort Program

Far too many diseases do not have a proven means of prevention or effective treatments. We must gain better insights into the biological, environmental, and behavioral influences on these diseases to make a difference for the millions of Americans who suffer from them. Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person. While some advances in precision medicine have been made, the practice is not currently in use for most diseases.

That’s why on January 20, 2015, President Obama announced the Precision Medicine Initiative® (PMI) in his State of the Union address. Through advances in research, technology and policies that empower patients, the PMI will enable a new era of medicine in which researchers, providers and patients work together to develop individualized care.

The President called for $215 million in fiscal year 2016 to support the Initiative, which includes several components with efforts from across the federal government. Of this total proposed budget, $130 million was allocated to NIH to build a national, large-scale research participant group, called a cohort, and $70 million was allocated to the National Cancer Institute to lead efforts in cancer genomics as part of PMI for Oncology.

The PMI Cohort Program will seek to extend precision medicine to all diseases by building a national research cohort of one million or more U.S. participants. Many factors have converged to make now the right time to begin a program of this scale and scope — Americans are engaging in improving their health and participating in health research more than ever before, electronic health records have been widely adopted, genomic analysis costs have dropped significantly, data science has become increasingly sophisticated, and health technologies have become mobile. The PMI Cohort Program will be a participant-engaged, data-driven enterprise supporting research at the intersection of human biology, behavior, genetics, environment, data science and computation, and much more to produce new knowledge with the goal of developing more effective ways to prolong health and treat disease.

The cohort will broadly reflect the diversity of the U.S. population by including participants from diverse social, racial/ethnic, and ancestral populations living in a variety of geographies, social environments, and economic circumstances, and from all age groups and health statuses. Information from the cohort will be a broad, powerful resource for researchers working on a variety of important health questions. The program will seek to extend precision medicine’s success to many diseases, including common diseases such as diabetes, heart disease, Alzheimer’s, obesity, and mental illnesses like depression, bipolar disorder, and schizophrenia, as well as rare diseases. Importantly, the cohort will focus not just on disease, but also on ways to increase an individual’s chances of remaining healthy throughout life. The goal of the PMI Cohort Program is to set the foundation for a new way of doing research that fosters open, responsible data sharing with the highest regard to participant privacy, and that puts engaged participants at the center of research efforts.

In March 2015, NIH Director Dr. Francis Collins tasked a Working Group of his Advisory Committee to the Director (ACD) to develop a plan for creating and managing a large research cohort. On September 17, 2015, Dr. Collins accepted the framework outlined in the Working Group report and is moving quickly to build the infrastructure so that participants can begin enrolling.